Senior Quality Control Analyst, Aspex Chemistry at ALCON (2024-03 – Present)
- Investigator responsible for communicating and collaborating with third party organizations for Laboratory Escalations
- Leading and organizing analyst's workload to ensure timely closure of investigations and sample management
- Coordinate cross-functional teams for investigation resolution
- Review and release of finished products and stability
- Other Senior Quality Analyst duties as needed, see below.
Principal Analyst, ESO Compliance at ALCON (2022-01 – 2023-12)
- Integrated Eysuvis and Inveltys Products and CMOs into Alcon ESO Organization
- QA contact for CMO production, investigations, complaints, change control and audits.
- Perform Technical Batch Release and Approval to Ship for multiple Raw Materials, Intermediates and Products
- Coordinate PO issuance as well as Finished Product and Stability delivery, testing and report generation with multiple Contract Laboratories
- Coordinate with Global Regulatory Affairs for product requests and submissions
Senior Quality Control Analyst at ALCON (2017-01 – 2022-12)
- Lead investigator responsible for communicating and collaborating with third party organizations for Laboratory Escalations
- Leading and organizing analyst's workload to ensure timely closure of investigations and sample management
- Review of laboratory methods against current compliance and regulatory standards
- Draft and provide lab assistance and guidance for Product and Process Change Control
- Coordinate cross-functional teams for investigation resolution
- Review and release of finished products and stability
- Reporting of Quality Metrics for QC Chemistry
- Data Integrity Subject Matter Expert for Laboratory personnel at the site
- Writing, reviewing and training others for investigational summaries and laboratory procedures and documentation
- Audit Team Support
- Project Management experience with lab improvement projects
- Method and instrumentation validation and qualification experience
- Standards Coordinator: Order, manage and inventory standards for the Chemistry Laboratory. Collaborate with Alcon and Novartis Standard Suppliers to order and manage standards to meet business continuity needs.
- Training of coworkers, analysts and contractors in instrument operation, calibration, maintenance and troubleshooting
- Test finished pharmaceutical and OTC products for in-process, complaint, release and stability testing. Utilize both instrumentation and wet chemistry techniques to test to manufacturing release specifications
R&D Chemist at ZS PHARMA (2016-01 – 2017-12)
- Worked individually and with the R&D team on investigations and investigation reports
- Testing of Research and Investigational samples via X-Ray Diffraction and Scanning Electron Microscopy
- Experience with FDA Audits as an R&D analyst
- Developed procedures for instrument use, data integrity/traceability and performance verifications
- Writing and review of documentation
- Process Development - Process improvements
- Scale Batches
- Cleaning Processes
- Established R&D sample submission, receipt, and chain of custody programs
Quality Assurance Analyst II – Component Chemistry at ALCON (2010-01 – 2016-12)
- Managed release timelines for chemicals and components - Expected turnaround time of two weeks for routine testing
- Expedited release in 1-3 days to support manufacturing demand.
- Review of daily and investigational samples.
- Writing and reviewing of documentation.
- Tested raw materials & packaging components utilizing both instrumentation and wet chemistry techniques to manufacturing release specifications including USP, EP, JP, and NOC specifications.
- Trained analysts and contractors in instrument operation and troubleshooting
- In charge of lab waste disposal, responsibilities include preparing wastes to be Lab-Packed, training coworkers in proper disposal techniques and disposing of aqueous wastes.
